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R&D Engineer
Galway
QC Manager
Dublin
Consultant
Cork
Biostatistician
Dublin City Centre
API Purchaser
Dublin
Snr QA Specialist
Dublin South
QA Manager
Meath
Program Manager
Westmeath
SAP Planner
Galway
Quality Engineer
Dublin South
QA Manager
Dublin North
R&D Engineer
Dublin
QA Manager Biologics
Dublin West
Administration Support
Dublin North
QA Manager
Dublin West
Project Engineer
Dublin North
National Sales Representative
Republic of Ireland
Supply Chain Analyst
Dublin North
Buyer
Dublin
Quality Assurance Manager
Republic of Ireland
QA Manager
Dublin
CTO
Galway
Risk Manager
Dublin
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Search Results for Regulatory Affairs Officer
Job Title. Location Salary Actions

Regulatory Affairs Associate

Regulatory Affairs Associate Our client is looking for a regulatory affairs associate who will deal with the compliance and approval of products. This person will also be responsible for determining and supporting regulatory activities. Responsibilities • Use technical solutions for problem solving • Improve quality of projects • Use strong writing skills to clearly define and describe technical information • Analyse customer complaints • Identify trends and corrective actions • Review and assess of change control activities for po...

Location: Westmeath,
Regulatory Affairs Associate
Westmeath Not Disclosed
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Regulatory Affairs Specialist Galway Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Senior Environmental Compliance Manager Dublin Not Disclosed
Head of Quality & Regulatory Affairs Dublin Not Disclosed
Quality Assurance and Regulatory Affairs Manager Dublin North Not Disclosed
Senior Regulatory Affairs Specialist Cork Not Disclosed
Regulatory Affairs Specialist Galway Not Disclosed

Regulatory Affairs Officer Career Profile

Regulatory Affairs Officer


The Regulatory Affairs (RA) department is tasked with ensuring that the company complies with all of the local and international regulations and laws pertaining to their business. The Regulatory Affairs Officer works with international, state and local regulatory agencies, such as the Irish Medicines Board (IMB), the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) on specific issues affecting their business. The Regulatory Affairs Officer advises the company on the current regulatory aspects and climate that would affect proposed activities. The RA Officer has many interactions within the medical affairs dept. including medical information, pharmacovigilance and clinical trials.

Key responsibilities of the Regulatory Affairs Officer


  • Maintenance of Irish and overseas licenses including preparation of variation and renewal applications as appropriate.
  • Preparation and submission of Marketing Authorisation applications to EU regulatory authorities.
  • Preparation of dossiers to obtain CE marking for medical devices.
  • Ensuring Labelling complies with appropriate legislation.
  • Ensure approved regulatory requirements are enforced in-house.
  • Participate in the development of electronic submission of dossiers.
  • Provide support to R&D projects; including new product introductions, changes to existing products and processes.
  • Liaise with suppliers, clients, development partners and regulatory bodies.
  • Ensure guidelines and knowledge of legislation is current and be able to advise of future developments and changes.
  • Monitor the process of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.